Taiwan FDA registration 2ce2832135c5b9efe7fd16c025922bcb
Immulite 2000 CMV IgM
TW: 免疫特巨細胞病毒免疫球蛋白M試劑
Taiwan·Risk Class 2·MD·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED·Registered Mar 31, 2015 – Mar 31, 2025ExpiredRegistration details
- Analysis ID
- 2ce2832135c5b9efe7fd16c025922bcb
- License Form
- Ministry of Health Medical Device Import No. 027194
- Customs Code
- DHA05602719400
Company information
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED
- Manufacturer Country
- United Kingdom
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- With the IMMULITE 2000 system, it is used to quantitatively detect cytomegalovirus (CMV) antibodies in human serum or plasma (EDTA or heparinized) to assist in the determination of acute CMV infection.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3175 CMV serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 31, 2015
- Expiry Date
- Mar 31, 2025
About this record
Access comprehensive regulatory information for Immulite 2000 CMV IgM in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2ce2832135c5b9efe7fd16c025922bcb and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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